Validation of a rapid and robust RP-HPLC method for quantification of triamcinolone: A unique approach for dosage and dissolution assays

Abstract High-performance liquid chromatography (HPLC) is a critical analytical technique in the pharmaceutical sector, valued for its accuracy, speed and efficiency in drug quantification. This study aimed to develop and validate a novel reversed-phase HPLC (RP-HPLC) method for quantifying triamcinolone base (TRb) in solid pharmaceutical forms, using consistent chromatographic conditions for both dosage determination and dissolution studies. The method was validated in accordance with regulatory guidelines and demonstrated excellent precision, accuracy, and robustness. The mobile phase consisted of methanol and water (50:50), with a flow rate of 1.5 mL min −1 , detection at 254 nm and a column temperature of 30 °C. Key performance parameters included selectivity, linearity ( R = 0.9998 across 2–12 μg mL −1 ), precision (RSD < 2%), accuracy (98–102% recovery in the presence of two placebo matrices), and robustness (seven variables evaluated without significant impact). The retention time was 4.61 min. The method proved effective for both dosage quantification and formulation dissolution studies. Applying the same methodology across various stages of pharmaceutical development enhances standardization, traceability, and data reliability. As such, this RP-HPLC method is highly recommended for quality control laboratories seeking practical, sustainable, and scientifically robust analytical solutions.